zolmiptriptan

Product NDC: 68462-499
11-digit product format: 684620499
Labeler code: 68462
Product ID: 68462-499_977ca814-2c55-4de0-a75e-9e42f2e86f77
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolmitriptan
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA202560
Marketing category: ANDA
Marketing start: 2013-05-14
Substance: ZOLMITRIPTAN
Active strength: 2.5 mg/1
Pharmacologic classes: Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202560-001	ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-14
A202560-002	ZOLMITRIPTAN	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202560-001	AB
A202560-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202560-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202560-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-05-14	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202560-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202560-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202560-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202560-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202560-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202560-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202560-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202560-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202560-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202560-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202560-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202560-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202560-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202560-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202560-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202560-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202560-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202560-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202560-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202560-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202560-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202560-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202560-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202560-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202560-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202560-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202560-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202560-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202560-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202560-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202560-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202560-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202560-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202560-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202560-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202560-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202560-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202560-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202560-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202560-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: zolmiptriptan
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZOLMITRIPTAN	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2FS66TH3YW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
284201	Internal RxNorm lookup
351134	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a734b368-6008-441c-ab44-5634e46be9a4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a0fbe307-6e31-a71d-5232-3216747b9b34	Product name	2	20220316
49286735-675f-7ca8-3815-48cfc7bb5a5a	Product name	9	20180828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-499-40	zolmiptriptan	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		14
68462-499-76	zolmiptriptan	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-499-40	EA - Each	68462-499	4b0634d1-9b03-4757-afd7-93ae71b1f9d1	1	2025-05-14
68462-499-76	EA - Each	68462-499	2d8abec8-745c-472e-8b24-d4de3fad1db2	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLMITRIPTAN	ACTIVE INGREDIENT	2FS66TH3YW	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6
ZOLMITRIPTAN	ACTIVE MOIETY	2FS66TH3YW	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-499	ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]	13	Current NDC, Legacy NDC, 2 package rows	20240705_a734b368-6008-441c-ab44-5634e46be9a4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
zolmiptriptan	ZOLMITRIPTAN	Glenmark Pharmaceuticals Inc., USA	a734b368-6008-441c-ab44-5634e46be9a4	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202560 application number: ANDA202560 ndc (product): 68462-499

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2FS66TH3YW	ZOLMITRIPTAN	139264-17-8	ZOLMITRIPTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
284201	ZOLMitriptan 2.5 MG Disintegrating Oral Tablet	PSN	a734b368-6008-441c-ab44-5634e46be9a4	14
351134	ZOLMitriptan 5 MG Disintegrating Oral Tablet	PSN	a734b368-6008-441c-ab44-5634e46be9a4	14
284201	zolmitriptan 2.5 MG Disintegrating Oral Tablet	SCD	a734b368-6008-441c-ab44-5634e46be9a4	14
351134	zolmitriptan 5 MG Disintegrating Oral Tablet	SCD	a734b368-6008-441c-ab44-5634e46be9a4	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-499-40	68462049940	6 in 1 BLISTER PACK						Historical
68462-499-76	68462049976	1 BLISTER PACK in 1 CARTON (68462-499-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68462-499-40)	1 blister pack	2013-05-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
zolmiptriptan	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	14